Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions (Fluxim)
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|ClinicalTrials.gov Identifier: NCT00928863|
Recruitment Status : Unknown
Verified May 2013 by Rosella Hermens, Radboud University.
Recruitment status was: Active, not recruiting
First Posted : June 26, 2009
Last Update Posted : May 24, 2013
|Condition or disease||Intervention/treatment|
|Hemorrhage, Postpartum||Other: implementation aids|
The most important cause of maternal morbidity in the Netherlands is Haemorrhagia post partum (HPP), with an incidence of 5% containing 10.000 women in the Netherlands a year. Introduction of an evidence-based guideline about HPP by the Dutch society of Obstetrics and Gynaecology (NVOG) and the course Management of Obstetrics Emergencies and Trauma (MOET course) did not lead to a reduction in HPP. This implies the possibility of an incomplete implementation of both the NVOG guideline and MOET-instructions.
To evaluate the implementation of the guideline and MOET instruction in the current care, measurement of the actual care will be performed in a representative sample of 20 hospitals. Before actual care can be measured, quality indicators have to be developed regarding the process, structure and outcome based on the key recommendations from the NVOG guideline on HPP and the MOET instructions. The indicator development will be performed according to the RAND-modified Delphi method .The key recommendations from the NVOG guideline on HPP and the MOET instructions will be extracted and will be tested in two rounds among an independent panel of 12-15. The selected key recommendations will be operationalized in measurable elements. In an observational multi-centre study, actual care will be measured by video monitoring the third stage of delivery and a medical record search among 320 high risk patients for HPP in 20 hospitals. Additional information for indicator adherence will be searched in the medical records of the videotaped patients. In this manner, deviations from the indicators can be outlined. This study will provide us with reliable information about current practice in the Netherlands.
A qualitative study will be performed with the aim to discover factors in detail that are "pro" or "contra" adhering to the developed HPP-indicators by focus group interviews among groups of different involved professionals and experienced patients. Subsequently, to assess the 'prevalence' of the factors mentioned in the focus group interviews, a survey with questionnaires will be performed among all Dutch gynaecologists and midwives. The data will be analyzed to assess the most frequently mentioned barriers and facilitators.
Based on the results of step 1 and 2, a tailored implementation strategy will be developed to increase the adherence to the recommendations. The different implementation elements will be tailored to the barriers and facilitators found and will probably combine interventions directed at professional and organizational level. This strategy will be implemented and evaluated in a feasibility study. The study will be performed in 3 hospitals where the effect of the implementation strategy, the adherence to the developed indicators will be measured. A process evaluation will be performed to study the experiences of the clinicians and patients with this strategy. A cost analysis of the tested implementation strategy will take place.
|Study Type :||Observational|
|Estimated Enrollment :||320 participants|
|Official Title:||Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
Haemorrhagia post partum
Women with a high risk for haemorrhagia post partum.
Other: implementation aids
testing a taylor made strategy for implementation NVOG guideline and MOET instruction in 3 hospitals
- actual care study: the primary outcome measure is the adherence to the quality indicators (derived from the NVOG guideline on HPP and the MOET instructions). [ Time Frame: 1 year ]
- feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators. [ Time Frame: 1 years ]
- barrier analysis [ Time Frame: 1 year ]the primary outcomes in the barrier analysis are the barriers and facilitators among patients and professional regarding adherence to the quality indicators
- actual care study: the secondary outcome measure is the outcome (e.g. the incidence of HPP) of care. [ Time Frame: 1 year ]
- feasibility study: the secondary outcome measures are the experiences of professionals and patients with the different elements of the implementation strategy and the changed care, and the cost of the tested strategy. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928863
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500 HB|
|Principal Investigator:||Rosella Hermens, PhD||IQ healthcare, Radboud University Nijmegen Medical Centre|